BCG VACCINE AJV

Kraj: Indonezja

Język: indonezyjski

Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Składnik aktywny:

LIVE ATTENUATED MYCOBACTERIUM BOVIS (BACILLUSS CALMETTE GUERIN STRAIN)

Dostępny od:

BIO FARMA - Indonesia

INN (International Nazwa):

LIVE ATTENUATED MYCOBACTERIUM BOVIS (BACILLUSS CALMETTE GUERIN STRAIN)

Dawkowanie:

0.75 MG

Forma farmaceutyczna:

SERBUK INJEKSI

Sztuk w opakowaniu:

DUS, 1 DUS @ 10 VIAL @ 0,75 MG (10 DOSIS DEWASA) + 1 DUS @ 10 VIA...

Wyprodukowano przez:

AJ VACCINE A/S - Denmark

Data autoryzacji:

2021-06-17

Charakterystyka produktu

CONFIDENTIAL
Page 1 of 7
09-Nov-2020
Final
BCG Vaccine AJV
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
BCG Vaccine AJV, powder and solvent for suspension for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.1 mL) for adults and children aged 12
months and over contains:
_Mycobacterium bovis_ (_M. bovis_) Bacillus Calmette-Guerin (BCG),
Danish strain 1331, live attenuated, 2-8 x
10
5
CFU.
After reconstitution, 1 dose (0.05 mL) for infants under 12 months of
age contains:
_M. bovis_ BCG, Danish strain 1331, live attenuated_,_ 1-4 x 10
5
CFU.
This is a multidose container. See Section 6.5 for the number of doses
per vial.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
White crystalline powder (might be difficult to see due to the small
amount in the vial). The solvent is a
colourless solution without any visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against tuberculosis.
BCG Vaccine AJV is to be used according to official national
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults, adolescents and children aged 12 months or more: _
\jor
ILIVaccines
DISETUJUI OLEH BPOM : 17 MEI 2021
EREG100409VR12100075
CONFIDENTIAL
Page 2 of 7
09-Nov-2020
Final
BCG Vaccine AJV
Summary of Product Characteristics
A dose of 0.1 mL of the reconstituted vaccine is injected strictly by
the intradermal route.
_Infants under 12 months of age:_
A dose of 0.05 mL of the reconstituted vaccine is injected strictly by
the intradermal route.
National recommendations should be consulted regarding the need for
tuberculin testing before
administration of BCG Vaccine AJV.
Method of Administration:
The injection site should be clean and dry. If antiseptics (such as
alcohol) are applied to swab the skin, they
should be allowed to evaporate completely before the injection is
given.
BCG Vaccine AJV must be administered